Abstract #300071

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JSM 2003 Abstract #300071
Activity Number: 57
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300071
Title: Decision Analysis of Phase II Clinical Trials
Author(s): Jie Zhang*+
Companies: Novartis Pharmaceuticals
Address: One Health Plaza, East Hanover, NJ, 07936-1016,
Keywords: Bayes method ; decision analysis
Abstract:

The purpose of many phase II clinical trials in the drug development is 1) to decide if a new drug or a new treatment should continue to develop, so large-scale and more expensive phase III confirmative trials can proceed (go, no go decision); and 2) to decide the optimum dose regimen for phase III trials. The decision process is extremely complicated, involves many different disciplines, and faces many challenge issues. In this paper, I will focus on one aspect of this decision process. I will propose a method using Bayes's approach to predict the probability of success of future phase III trials based on current phase II results, previous knowledge of the new compound, and experience on standard treatment. I will also illustrate how to use the method to calculate the sample size for phase III trials. In addition, I will compare this method with standard sample size calculation method. Lastly, I will provide an example to illustrate the approach.

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